Dating Violence Prevention Program Focusing on Middle School Boys

This study will test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Dating Violence
• Intervention / Treatment: Behavioral: Project STRONG; Behavioral: Health Promotion

Detailed Description

Over the past ten years dating violence (DV) has been recognized as a significant public health problem affecting adolescents. Emerging data suggest that boys and girls have different developmental trajectories toward violence and therefore prevention programs that target their unique pathways to DV are needed. Despite this need, there is a relative dearth of such gender-informed programs for early adolescent boys. This research project aims to prevent the emergence of DV perpetration/ victimization among boys by developing a web-based intervention that is informed by research on gender-specific pathways to violence and harnesses the influence of parents during the early adolescent years.

Among boys, the perpetration of delinquency-related violence and attitudes supporting violence has been found to predict later perpetration of DV. Thus, gender-informed interventions designed to prevent DV in boys need to target skills that underlie violent behavior and attitudes. The goal of this study is to test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to prevent DV.

A pilot trial was conducted to create and test the efficacy of the web-based intervention. Preliminary results suggested the program was effective in reducing dating-violence involvement. This Randomized Controlled Trial (RCT) will test the efficacy of the intervention against an active control designed to provide health related information in a format similar to that of the intervention condition. 340 families (English or Spanish-speaking) will be randomly assigned to complete the intervention program or the health-promotion control program. All families will complete the program in an observed setting, to ensure fidelity to intervention dosing. Parents and adolescents will complete the program together and then complete assessments of aggressive and risk behaviors, parent-child communication, and emotion regulation at baseline, 3-month,6-month, 12-month, 18-month, and 24-month follow-ups.

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 09203
      • Recruiting
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. adolescent is between 12 and 15 years old
2. adolescent identifies as male
3. adolescent enrolled in the 7th or 8th grade at a participating school,
4. parent/legal guardian and teen are English or Spanish speaking,
5. parent/legal guardian and son reside together at least 50% of the time,
6. parent/legal guardian is willing to provide consent for the adolescent to participate in the study,
7. adolescent is willing to provide assent for their own participation.

Exclusion Criteria:

1. adolescent or parent is unable to read at a 4th grade level or has developmental delays,
2. other family members in household have previously participated in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Project STRONG; Project STRONG is an active skill-based intervention designed to prevent adolescent dating violence among middle school boys. Boys and a parent will complete the web-based program together focusing on improving communication and emotion regulation.	Behavioral: Project STRONG; Project STRONG is a 6-module web-based, dyadic intervention for middle school boys and their parents to complete. Its goal is primary prevention of adolescent dating violence by targeting parent-child communication and emotion regulation ability.
Active Comparator: Health Promotion; Health Promotion is an information-based program designed to mimic content areas provided during middle-school health education. The content is provided via a web-based interface to mirror the content delivery in the active intervention (Project STRONG).	Behavioral: Health Promotion; Health promotion is a 6 module web-based, health information program designed to provide health content similar to that provided in a middle school health class. This program is designed to mirror Project STRONG for time and delivery method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dating violence perpetration and victimization from baseline to 24-months	The Conflict in Adolescent Dating Relationships Inventory (CADRI), completed by dating teens, assesses verbal, emotional, physical, and sexual dating abuse perpetration and victimization with a current or recent dating partner. The CADRI has strong internal consistency (total α=.83) and 2-week test retest reliability, r=.68, p<.01, as well as acceptable partner agreement (r=.64, p<.01).	At baseline, participants will report lifetime and past 6-month DV. For all other time points we will assess the past 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of relationship from baseline to 24 months	The Relationship Inventory will obtain general information about adolescents' romantic relationships via 11 items assessing number of relationships, duration, time since last relationship, and number of relationships terminated or not initiated due to concerns about DV.	Baseline, 3, 6, 12, 18, 24 months
Change in attitudes about relationship violence from baseline to 24 months	Attitudes about Relationship Violence Questionnaire (ARVQ; 39 items), completed by parents and teens, assesses knowledge, attitudes, and methods of dealing with DV (subscale αs = .75 -.87).	Baseline, 3, 6, 12, 18, 24 month followup
Change in aggressive behavior from baseline to 24 months	The Aggression Questionnaire (AQ)110 has 34 items that rate five types of aggression (e.g., physical, verbal) (α=.94, rtt =.80, total score).	Baseline, 3, 6, 12, 18, 24 month followup
Change in digital abuse behaviors from baseline to 24 months	The Electronic Behaviors in Adolescent Relationships (EBAR) assesses digital forms of DV perpetration and victimization through 32 items	Baseline, 6, 12, 18, 24 month followup

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of sexual and substance use behaviors from baseline to 24 months	The Adolescent Risk Behavior Assessment (ARBA) will assess sexual behavior, including behaviors relevant to this developmental period (e.g., kissing, breast fondling) using previously validated items from the Psychosexual Development Interview (PDI)113. A modified version of the substance use section of the ARBA will assess use of alcohol, marijuana, inhalants, and other drugs.	Baseline, 6, 12, 18, 24 month followup
Change in bullying behaviors from baseline to 24 months	The Illinois Bully Scale (IBS)is a self-report measure assessing the frequency of fighting, peer victimization, and bully behavior (α = 0.88).	Baseline, 6, 12, 18, 24 month followup
School discipline actions from baseline to 24 months	School records of attendance, suspensions, and detentions will be collected to assess discipline problems, which may change as a result of changes in ER and aggressive behaviors. These measures will be calculated as a percent of school days in the assessment period, to adjust for vacations. Participating school districts use electronic systems to record this data; these variables will be collected from these systems	24 month followup

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): April 30, 2025
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R01HD097126 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per NIH data sharing policy (2015), within one year of completion of the study and dissemination of primary study results, deidentified datasets will be made available to the public, along with the final version of the study protocol, data dictionaries, and brief instructions.
• IPD Sharing Time Frame: Data will be deposited within one year of dissemination of primary study results to the National Institute of Child Health and Human Development Data and Specimen Hub (DASH). Access will be managed by DASH.
• IPD Sharing Access Criteria: Access to the deidentified data will be managed by DASH.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No